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Home > "T" Clinical Trials Conditions > Thalidomide in Treating Anemia in Patients With Myelodysplastic Syndrome  Thalidomide in Treating Anemia in Patients With Myelodysplastic Syndrome
Thalidomide in Treating Anemia in Patients With Myelodysplastic Syndrome
For Condition: myelodysplastic and myeloproliferative disease,atypical chronic myeloid leukemia,Chronic Myelomonocytic Leukemia,Myelodysplastic Syndromes
Status: Completed
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Thalidomide may be an effective treatment for anemia caused by myelodysplastic syndrome. PURPOSE: Randomized phase II trial to study the effectiveness of thalidomide in treating anemia in patients who have myelodysplastic syndrome.
Details: OBJECTIVES: - Determine the efficacy of thalidomide for the treatment of anemia in patients with myelodysplastic syndromes. - Determine whether this drug reduces the frequency of leukemia transformation and decreases bone marrow blast percentage in these patients. - Determine the effect of this drug on neutrophil and platelet production and the number of episodes of febrile neutropenia in these patients. - Determine the safety of this drug in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to International Prognostic Scoring System score (low and intermediate-1 vs intermediate-2 and high) and transfusion dependence (yes vs no). Patients are randomized to one of two treatment arms. - Arm I: Patients receive oral thalidomide once daily on weeks 1-24. - Arm II: Patients receive oral placebo once daily on weeks 1-24. In both arms, patients who have not progressed to leukemia after 24 weeks of therapy may receive open-label thalidomide for an additional 24 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of myelodysplastic syndromes (MDS) of at least 12 weeks duration - Refractory anemia (RA) - RA with ringed sideroblasts - RA with excess blasts - Chronic myelomonocytic - No therapy-related MDS - No myelosclerosis or myelofibrosis occupying more than 30% of marrow space (or assessed as grade 3+ or greater) - No transformation to acute myeloid leukemia - No more than 20% blasts in bone marrow - No more than 5% blasts in peripheral blood - Patients with an erythropoietin level 100 mU/mL or less must have failed epoetin alfa treatment (i.e., at least 30,000 units of epoetin alfa weekly for at least 6 weeks) - Transfusion-dependent (received at least 2 units of packed RBCs or whole blood within the past 8 weeks) OR - Transfusion-independent (no packed RBC or whole blood transfusions within the past 8 weeks with 2 hemoglobin levels (at least 7 days apart) less than 11 g/dL) - No iron deficiency (e.g., absent bone marrow iron store) - If marrow aspirate is not evaluable, transferrin saturation must be at least 20% and ferritin at least 50 ng/mL - No uncorrected B12 or folate deficiency - No other contributing causes of anemia (e.g., autoimmune or hereditary hemolytic disorders or gastrointestinal blood loss) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Zubrod 0-2 Life expectancy: - At least 6 months Hematopoietic: - See Disease Characteristics - Absolute neutrophil count at least 500/mm^3 Hepatic: - Bilirubin no greater than 2.0 mg/dL - AST and ALT less than 2 times upper limit of normal (ULN) - Hepatitis B surface antigen negative - Hepatitis C negative Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No uncontrolled hypertension - No clinically significant, symptomatic, unstable cardiovascular disease unrelated to MDS Pulmonary: - No clinically significant, symptomatic, unstable pulmonary disease unrelated to MDS Neurologic: - No clinically significant, symptomatic, unstable neurologic disease unrelated to MDS - No history of epilepsy - No sustained neurologic deficit (e.g., stroke) - No grade 2 or greater peripheral neuropathy Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use at least 1 highly effective and 1 additional effective method of contraception for 4 weeks prior to, during, and for 4 weeks after study participation - HIV negative - No clinically significant, symptomatic, unstable endocrine, gastrointestinal, or genitourinary disease unrelated to MDS - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No life-threatening or active infection requiring parenteral antibiotics - No other serious concurrent illness PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - More than 7 days since prior hematopoietic growth factors (e.g., epoetin alfa, filgrastim (G-CSF), sargramostim (GM-CSF), or interleukin-3) - No prior thalidomide - No prior agents intended to inhibit vascular endothelial growth factor or tumor necrosis factor alfa (e.g., etanercept or infliximab) - No concurrent epoetin alfa Chemotherapy: - No concurrent chemotherapy that may be active against MDS Endocrine therapy: - More than 30 days since prior androgens - No requirement for ongoing therapy with systemic corticosteroids Radiotherapy: - Not specified Surgery: - Not specified Other: - More than 30 days since prior treatment for MDS except RBC transfusion or epoetin alfa - More than 30 days since prior participation in another experimental clinical trial - More than 30 days since prior experimental drugs - No other concurrent investigational agents or treatments
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesSlack, Study Chair, Roswell Park Cancer Institute
PPD Development
Wilmington, North Carolina, 28412
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Additional Information:
Study ID Numbers: CDR0000069176; CELGENE-T-MDS-001,NCI-G01-2044,RPCI-DS-0116
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030550
Other Myelodysplastic Syndromes Studies:
1. Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders
2. Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
3. Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
4. Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome
5. Chemotherapy Plus Bone Marrow Transplantation and Filgrastim in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Related Studies:
Other Myelodysplastic Syndromes Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Thalidomide in Treating Anemia in Patients With Myelodysplastic Syndrome
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